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Clinical Evaluation of a Novel Wearable Compression Technology in the Treatment of Lymphedema, An Open-Label Controlled Study

NCT04659564 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-06-01

No results posted yet for this study

Summary

An open-label study to clinically assess a novel wearable advanced compression technology (Dayspring™) undertaken to determine if potential barriers to lymphedema self-care were effectively addressed. The Dayspring™ device is a novel FDA-cleared wearable solution that is portable and easy-to-use sequential compression system. The following endpoints are examined:

1. Improvement in QoL in subject with upper-extremity edema after 28 days as measured by the LYMQOL disease-specific validated assessment tool.
2. Arm volume maintenance or improvement as measured prior to and after 28 days of device use.
3. Safety as assessed by reported adverse events
4. Patient satisfaction as measured by visual analog scale (VAS) and survey at the end of the study; and
5. Adherence to therapy as measured with a smart phone app.

Conditions

  • Breast Cancer Related Lymphedema
  • Lymphedema of Upper Arm
  • Lymphedema
  • Quality of Life

Interventions

DEVICE

User of Dayspring device

The Dayspring™ device is a novel FDA-cleared wearable solution that is portable and easy-to-use sequential compression system.

Sponsors & Collaborators

  • Koya Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Stanley G Rockson, MD · Medical Advisor

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-05
Primary Completion
2021-05-28
Completion
2021-05-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04659564 on ClinicalTrials.gov